Paxil Is Not Safe or Effective For Teens

In a new review of data from a 2001 trial, researchers say there is no evidence that paroxetine (Paxil), an antidepressant that is approved for treating depression, obsessive-compulsive disorder and social anxiety in adults, is effective or safe for teens. The original study had stated that paroxetine is "generally well tolerated and effective for major depression in adolescents."

In the re-analysis, published in the BMJ, an international group of scientists conducted a thorough review of Study 329, which was originally published in the Journal of the American Academy of Child and Adolescent Psychiatry. Since its publication, reports of suicidal thoughts and behavior among teens taking the drug raised questions about paroxetine’s effectiveness and safety, and in 2002 the U.S. Food and Drug Administration began investigating the drug’s potential dangers among adolescents. The following year, the agency advised doctors not to prescribe it to teens suffering from depression.

Doctors and researchers have called for the journal editors to retract or revise the paper; the editor-in-chief, after reviewing it, ultimately said there was "no basis [was] found for editorial action against the article."

Only one antidepressant, fluoxetine (Prozac) is approved by the FDA for treating depression in teens. But other medications in the same class, known as selective serotonin reuptake inhibitors (SSRIs), are commonly prescribed by doctors for younger patients in so-called off label use. Their comfort in doing so comes from trials like Study 329.

Jon Jureidini, professor and research leader of critical and ethical mental health at the University of Adelaide, charges that the authors of the original 2001 paper "deliberately misrepresented the outcomes of the study" and changed the protocols of the study without following the proper procedures to do so.